The following data is part of a premarket notification filed by Ldr Spine Usa Inc. with the FDA for Easyspine System.
| Device ID | K123134 |
| 510k Number | K123134 |
| Device Name: | EASYSPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662663002479 | K123134 | 000 |
| 03662663002288 | K123134 | 000 |
| 03662663002271 | K123134 | 000 |
| 03662663002264 | K123134 | 000 |
| 03662663002257 | K123134 | 000 |
| 03662663002240 | K123134 | 000 |
| 03662663002233 | K123134 | 000 |
| 03662663002226 | K123134 | 000 |
| 03662663002219 | K123134 | 000 |
| 03662663002202 | K123134 | 000 |
| 03662663002196 | K123134 | 000 |
| 03662663002189 | K123134 | 000 |
| 03662663002172 | K123134 | 000 |
| 03662663002165 | K123134 | 000 |
| 03662663002158 | K123134 | 000 |
| 03662663002141 | K123134 | 000 |
| 03662663002295 | K123134 | 000 |
| 03662663002301 | K123134 | 000 |
| 03662663002462 | K123134 | 000 |
| 03662663002455 | K123134 | 000 |
| 03662663002448 | K123134 | 000 |
| 03662663002431 | K123134 | 000 |
| 03662663002424 | K123134 | 000 |
| 03662663002417 | K123134 | 000 |
| 03662663002400 | K123134 | 000 |
| 03662663002394 | K123134 | 000 |
| 03662663002387 | K123134 | 000 |
| 03662663002370 | K123134 | 000 |
| 03662663002363 | K123134 | 000 |
| 03662663002356 | K123134 | 000 |
| 03662663002349 | K123134 | 000 |
| 03662663002332 | K123134 | 000 |
| 03662663002318 | K123134 | 000 |
| 03662663002134 | K123134 | 000 |